On JUne 4, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of updated results from a prospective, multicenter study demonstrating the accuracy and performance of DecisionDx-Melanoma at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from May 31-June 4 (Press release, Castle Biosciences, JUN 4, 2019, View Source [SID1234536891]).

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The study titled, "Three year survival outcomes in a prospective cohort evaluating a prognostic 31 gene expression profile (31-GEP) test for cutaneous melanoma" (Abstract #9519), was presented at ASCO (Free ASCO Whitepaper) during the Poster Discussion Session: Melanoma/Skin Cancers. Previously an initial report of this cohort was published with a median follow-up of 1.5 years.

This second report, with a median follow-up of 3.2 years, emphasized three points of analysis:

Whether the study’s extended results demonstrate the accuracy of DecisionDx-Melanoma in predicting risk of recurrence, as previously reported.
Whether the prospective outcomes in patients with cutaneous melanoma tumors ≤2 mm thick (pathologic stage T1-T2) who had a low-risk DecisionDx-Melanoma Class 1A test result support the use of the test for guiding sentinel lymph node biopsy (SLNB) surgery decisions.
Overall, whether the study results show that DecisionDx-Melanoma can offer improvements in patient treatment beyond American Joint Committee on Cancer (AJCC) staging.
Key Study Findings

Patients with the highest risk DecisionDx-Melanoma result (Class 2B) had significantly reduced recurrence-free survival, distant metastasis-free survival and overall survival (OS) compared to patients with the lowest risk (Class 1A) result (p≤0.0001), consistent with three previously published prospective studies.
In the subgroup of patients with T1-T2 melanoma tumors, in which DecisionDx-Melanoma has been shown to predict sentinel lymph node status, Class 1A results were associated with favorable prognosis (OS=99.4%). This confirms the favorable prognosis in T1-T2 Class 1A melanomas reported in a long-term archival tissue study (5-year OS=98.2%) and provides support for the use of a Class 1A test result to identify patients at low risk for a positive SLNB surgery result and excellent prognosis who can avoid this surgical procedure.
DecisionDx-Melanoma Class 2B result was a significant, independent predictor of recurrence, distant metastasis and mortality compared to AJCC staging (Stages IIB-III; p<0.05) in multivariate regression analysis. Furthermore, the hazard ratio for OS was 9.35 for a high risk Class 2B result compared to 2.33 for AJCC high risk.
These prospective results demonstrate that DecisionDx-Melanoma is an accurate, independent predictor of outcomes, including in specific subgroups for whom the test has previously been shown to predict likelihood of recurrence and SLN positivity.
"A substantial proportion of melanoma-related deaths occur among patients who were traditionally staged as low risk, highlighting the importance of the improved risk prediction seen in this study," commented investigator Eddy C. Hsueh, M.D., Professor and Director, Division of General Surgery, St. Louis University Hospital. "Use of DecisionDx-Melanoma to improve outcome prediction over traditional staging alone can result in more informed treatment management decisions including appropriate use of sentinel lymph node biopsy, surveillance and follow-up."

Study Details:

Patients were prospectively enrolled in one of two clinical registries that were established to track patient outcomes and clinical utility. All patients underwent DecisionDx-Melanoma testing as part of their melanoma assessment.

The cohort included 342 patients with AJCC Stage I-III melanoma from 11 U.S. dermatologic and surgical centers with a median age of 58 years. The majority of patients (89%) had AJCC Stage I or II melanoma. Median Breslow thickness was 1.2 mm; 260 patients had tumors 2.0 mm thick or less (T1-T2). Median follow-up was 3.2 years for patients who did not experience an event.

The poster can be found in the Publications section of the Castle Biosciences website.

Additional Castle Biosciences Data at 2019 ASCO (Free ASCO Whitepaper)

Data demonstrating the economic impact of DecisionDx-Melanoma in Medicare-eligible patients were also presented as a poster at the 2019 ASCO (Free ASCO Whitepaper) meeting (Abstract #6630).

An economic model was developed to perform a cost-benefit analysis for use of the DecisionDx-Melanoma test to inform patient treatment decisions. Results from the economic model suggest that using the test to guide decisions regarding the SLNB surgery, completion lymph node dissection and surveillance for a Medicare-eligible population offers significant cost savings compared to traditional care. A net cost reduction is retained with addition of DecisionDx-Melanoma testing to guide surveillance decisions in Medicare-eligible patients with melanoma tumors greater than 2 mm thick (T3-T4). Combined with previously published data showing that patients ≥65 years with Class 1A, T1-T2 melanoma have low SLN positivity and favorable outcomes, the model can be used to determine the cost-benefit of using the DecisionDx-Melanoma test to guide SLNB decisions for Medicare-eligible patients.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 3,100 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and five prospective risk of recurrence studies including more than 780 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included more than 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

More information about the test and disease can be found at www.SkinMelanoma.com.

On June 4, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (the "Company") reported that Mr. Peter Greenleaf, Chief Executive Officer, will present a corporate overview at the following upcoming investor conferences (Press release, Aurinia Pharmaceuticals, JUN 4, 2019, View Source [SID1234536890]):

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Jefferies Healthcare Conference on Friday, June 7, 2019 at 9:30am PT (12:30pm ET) in New York, NY; and
Raymond James 2019 Life Sciences and MedTech Conference on Tuesday, June 18, 2019 at 5:35am (8:35am ET) in New York, NY.
All presentations will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of each presentation will also be archived on the Company website following the event.

On June 4, 2019 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will present at the Goldman Sachs 40th Annual Global Healthcare Conference at 10:00 a.m. PT (1:00 p.m. ET) on Tuesday, June 11, 2019, in Rancho Palos Verdes, Calif. Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, of Neurocrine Biosciences will present at the conference (Press release, Neurocrine Biosciences, JUN 4, 2019, View Source [SID1234536889]).

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On June 4, 2019 Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics targeting essential kinases, reported the completion of clinical trial supply manufacture for PMD-026 (Press release, Phoenix Molecular Designs, JUN 4, 2019, View Source [SID1234536888]).

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PhoenixMD’s lead program, PMD-026, is the first RSK inhibitor built for the treatment of triple-negative breast cancer (TNBC). The clinical trial supply was undertaken by STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, and is being used to support IND-enabling toxicology studies and an upcoming Phase I/Ib study in women with breast cancer.

In March 2018, the companies entered into a major manufacturing agreement, and have since produced a multi kilogram drug supply for PMD-026 under GMP manufacturing practices. This represents a significant milestone, accelerating PhoenixMD’s Phase I readiness.

In order to further the collaboration, WuXi STA expanded its USA operations to include capsule production under GMP regulatory compliance. Dr. Minzhang Chen, CEO of WuXi STA, commented "The opportunity to enable PhoenixMD’s first-in-man studies came at an opportune moment for STA’s San Diego facility."

"Our partnership with WuXi STA has been critical for PhoenixMD to advance this stage of our development. Working with such a high quality, globally recognized manufacturing partner has allowed us to rapidly advance PMD-026 through IND-enabling GLP toxicology studies and has enabled us to be ready to initiate our Phase I/Ib study with high quality API in capsules," said Sandra E. Dunn, CEO of PhoenixMD. "The rapid achievement of this milestone brings us one step closer to initiating our study for women suffering from breast cancer. More specifically, metastatic triple-negative breast cancer, which is the most deadly type of breast cancer. RSK2 is a promising new drug target for the treatment of TNBC, and PMD-026 is the first drug to ever reach clinical use against this novel target."

"The secret sauce in our success – teamwork. We truly appreciate the collaborative approach and commitment that WuXi STA has brought to the PMD-026 project," notes Dr. Dunn.

The drug supply is sufficient to treat all of the patients in the Phase 1 study. This is coupled with the completion of PhoenixMD’s CDx for measuring activated RSK2 in tumors signals, enabling the two key elements needed for this precisely designed clinical trial to advance.

About RSK kinases in refractory cancers such as Triple Negative Breast Cancer (TNBC)

RSK is commonly associated with refractory cancers such as TNBC, hormone-refractory prostate cancer and resistant melanoma. Beyond these cancers, it is commonly activated in ovarian and colorectal cancers. RSK1 and RSK2 have been proven critical to the survival of patients with TNBC. Over 90% of primary TNBC express high levels of RSK1 and RSK2 mRNA and at the protein level RSK2 is activated in ~89% of primary tumors. Inhibiting RSK2 induces cell death in TNBC cells and is synergistic with standard of care chemotherapies such as paclitaxel. PhoenixMD, with its novel, targeted approach, is focused on creating patented RSK inhibitors and companion diagnostics for cancer indications – initially in breast cancer – with the potential to treat blood, brain, ovarian, lung, skin, prostate, colon, head and neck cancers.

Approximately 400,000 cases of TNBC are diagnosed every year worldwide and it is one of the most difficult breast cancer subtypes to treat due to lack of effective, targeted therapies. TNBC also claims the lives of young women more than any other type of breast cancer due to a lack of understanding around the therapeutic bullseye. This refractory disease is also a very heterogeneous disease, therefore a common denominator across TNBC types was necessary to identify the bullseye. Through genome-wide screens, RSK was identified as the prime target for TNBC by scientists at PhoenixMD. Currently, there are limited targeted therapies available for TNBC making RSK a leading opportunity.

There are four types of RSK involved in cancer, known as RSK1-4, and each type has a unique role in the development of the disease. RSK1 is responsible for cancer cell invasion and is an important driver in the spread of cancer. RSK2 controls cancer cell growth, and RSK3 and RSK4 are associated with drug resistance.

Currently, there are a limited number of approved targeted therapies for TNBC, however tumor progression continues to be eminent in most patients. PhoenixMD is addressing this unmet medical need through a novel, targeted approach by inhibiting critical kinases, such as RSK1-4, a group of highly conserved Ser/Thr kinases that promote cell proliferation, growth, motility and survival. For this target, PhoenixMD developed PMD-026, a first-in-class, specific RSK inhibitor that blocks downstream signaling of RSK and induces apoptosis.

About PMD-026 for TNBC

PhoenixMD’s lead program, PMD-026, is the first RSK inhibitor built for the treatment of triple-negative breast cancer (TNBC). PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase that drives the growth of this breast cancer subtype relative to hormone positive or Her-2 positive breast cancers. RSK2 was identified in a functional screen profiling 519 potential kinases. PMD-026 is the first drug to specifically arise from functional dependency screens in TNBC. PMD-026 is applicable to greater than 14 different types of cancers including those resistant to a wide range of therapies.

The first in human clinical trial for PMD-026 is a Phase I/Ib that is scheduled to initiate in Q3- 2019. Importantly, the clinical trial will include a companion diagnostic (CDx) that links PMD-026 to RSK2 activation in tumors, which PMD is developing in collaboration with Roche. In preclinical studies, PMD-026 shrinks tumors by over 70% as a single agent after only two weeks of treatment in tumors with high RSK2 activation using their CDx for model selection.

PMD-026 is shown to unlock the potential of tumor resistance by synergizing with chemotherapies such as paclitaxel. More recently, PMD-026 demonstrated the potential to reprogram the way that TNBC is recognized by the immune system, in part, by inhibiting PD-L1.

On June 4, 2019 Eisai reported additional data from an ongoing Phase 1 trial exploring the investigational combination of eribulin and balixafortide, a CXCR4 antagonist, in patients with HER2-negative metastatic breast cancer (Abstract #2606), were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from May 31-June 4 (Press release, Eisai, JUN 4, 2019, View Source [SID1234536887]).

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This open-label, single-arm, Phase 1 trial enrolled 56 HER2-negative, CXCR4-positive women age 18 years or older with metastatic breast cancer (MBC), and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, who had previously received one to three chemotherapy regimens for MBC. The primary endpoints were incidence of dose-limiting toxicities; type, frequency, and severity of adverse events; establishment of the maximum tolerated dose or the highest dose if no dose-limiting toxicity was observed; and pharmacokinetic parameters. Secondary objectives were progression-free survival, overall survival, and the proportion of patients who achieved an objective response.1 Initial data were published in The Lancet Oncology and initial median OS data were presented at ESMO (Free ESMO Whitepaper) 2018. New at ASCO (Free ASCO Whitepaper) are the landmark overall survival (OS) data.

For patients who received the combination of eribulin and balixafortide second line or later in the expanded cohort (EC), the landmark OS at 18 months was 50% (95% CI: 29.1-67.8) and at 24 months was 33.3% (95% CI: 15.9-51.9). For these patients in the overall efficacy population (OEP), the landmark OS at 18 months was 42.4% (95% CI: 28.9-55.2) and at 24 months was 25% (95% CI: 14.3-37.3).
For patients who received the combination of eribulin and balixafortide third line or later in the EC, the landmark OS at 18 months was 40% (95% CI: 19.3-60.0) and at 24 months was 25% (95% CI: 9.1-44.9). For these patients in the OEP, the landmark OS at 18 months was 32.5% (95% CI: 18.3-47.6) and at 24 months was 19% (95% CI: 8.4-32.9).
The landmark 18 month and 24 month overall survival data are consistent with the efficacy data previously observed from this study; safety information is consistent with previous reports. In the study, the most frequently (>40%) reported adverse events were fatigue (79%), neutropenia (57%), infusion-related reactions (48%), constipation (46%), alopecia (46%) and nausea (45%).

"We are encouraged by the results of this study for patients who received the combination of eribulin and balixafortide as second line or later therapy for the treatment of HER-2 negative metastatic breast cancer," said David D’Adamo, MD, PhD, Senior Director, Clinical Research, Oncology at Eisai. "With up to 6 percent of new breast cancer cases diagnosed as metastatic, this combination merits further investigation in patients with HER-2 negative metastatic breast cancer as we continue our quest for potential new treatment options."

CRX4 plays a critical role in tumor growth, survival, angiogenesis and metastasis. High CXCR4 levels are correlated with aggressive metastatic phenotypes and poor prognosis in breast cancer.2 Preclinical evidence suggests that disrupting CXCR4-dependent pathways prevents development of breast cancer metastases, enhances the cytotoxic effect of chemotherapy and immunotherapy, and counteracts tumor cell evasion of the immune system.3

This release discusses an investigational compound and investigational use for an FDA-approved product. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

About the Study
In this open-label, single-arm, Phase I trial, patients received HALAVEN (eribulin) with increasing doses of balixafortide (0.5−5.5mg/kg) using a standard 3+3 dose escalation design followed by an expanded cohort at the highest dose of balixafortide as no dose limiting toxicity was observed. The majority of patients received eribulin 1.4mg/m2, although Cohorts 2 and 3 received eribulin 1.1mg/m2. This trial enrolled 56 HER2-negative, CXCR4-positive females age ≥ 18 years with MBC, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, who had previously received 1−3 chemotherapy regimens for MBC. All cohorts received 21-day Cycles of eribulin on Days 2 and 9, and balixafortide on Days 1−3, and 8−10. Cohorts 2−4 also received a 28-day run-in Cycle to better assess safety and potential pharmacokinetic interactions. All patients received treatment until disease progression or unacceptable toxicity.

The primary endpoints were incidence of dose-limiting toxicities; type, frequency, and severity of adverse events; establishment of the maximum tolerated dose or the highest dose if no dose-limiting toxicity was observed; and pharmacokinetic parameters. Secondary objectives were progression-free survival, overall survival, and the proportion of patients who achieved an objective response. In patients who received the combination of eribulin and balixafortide as second line or later therapy, the objective response rate (ORR) was 38% (95% CI: 19 – 59), median progression free survival (PFS) was 6.2 months (95% CI 2.9–8.1), and median OS was 18 months for the EC, and 30% (95% CI: 18 – 44), 4.6 months (95% CI: 3.1 – 5.7) and 16.8 months for the OEP, respectively. The association between various baseline biomarkers and treatment outcomes (including OS) were investigated in a multivariate analysis. Safety information was consistent with previous reports, and the most frequently (>40%) reported adverse events were fatigue (79%), neutropenia (57%), infusion-related reactions (48%), constipation (46%), alopecia (46%) and nausea (45%). Initial data were published in The Lancet Oncology and presented at ESMO (Free ESMO Whitepaper) 2018. Further data from the multivariate analysis will be presented in full later this year.

About HALAVEN (eribulin mesylate) Injection
HALAVEN (eribulin mesylate) Injection is a microtubule dynamics inhibitor indicated for the treatment of patients with:

Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor. Eribulin is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype. Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells.

Important Safety Information

Warnings and Precautions

Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.

Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.

Embryo-Fetal Toxicity: HALAVEN can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose.

QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.

Adverse Reactions
In patients with mBC receiving HALAVEN, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).

In patients with liposarcoma and leiomyosarcoma receiving HALAVEN, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reactions resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).

Use in Specific Populations

Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.

Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.

For more information about HALAVEN, click here for the full Prescribing Information.

HALAVEN is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.